CN110772223A

CN110772223A - Dual frequency control for physiological monitors

Info

Publication number: CN110772223A
Application number: CN201910695257.6A
Authority: CN
Inventors: A.戈瓦里; Y.埃弗拉斯; A.C.阿尔特曼
Original assignee: Biosense Webster Israel Ltd
Current assignee: Biosense Webster Israel Ltd
Priority date: 2018-07-30
Filing date: 2019-07-30
Publication date: 2020-02-11
Also published as: IL267545A; US10736509B2; JP2020018850A; CA3050559A1; US20200029812A1; AU2019204309A1; IL267545B; EP3605552A1

Abstract

The invention relates to a dual frequency control for a physiological monitor. A physiological monitoring device is configured to detect and record signals from sensors, and to wirelessly communicate with a transmitter and receiver disposed outside of a housing via a communication interface, and to receive transmissions of commands and data from the transmitter via the communication interface. The device operates in a standby mode and an active mode. Transmitting includes a control signal for changing an operating mode, the control signal transmitted by the transmitter at a first frequency in a range of 1GHz-10 GHz; and transmission of recorded data from the sensor to the receiver in the range 400MHz-450 MHz.

Description

Dual frequency control for physiological monitors

Copyright notice

A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the patent and trademark office patent file or records, but otherwise reserves all copyright rights whatsoever.

Background

1. Field of the invention

The present invention relates to remote physiological monitoring using telemetry. More particularly, the present invention relates to wireless communication with an infusion heart rhythm monitor.

2. Description of the related Art

The meanings of certain acronyms and abbreviations used herein are given in table 1.

Table 1: acronyms and abbreviations

ECG	Electrocardiogram
		ICM	Plug-in heart rhythm monitor
ISM	Industrial, scientific and medical treatment
		MICS	Mobile information and communication system
NFC	Near field communication
		NVM	Nonvolatile memory
RF	Radio frequency
		RFID	Radio frequency identification
SPI	Serial peripheral interface
		SRAM	Static random access memory

Various types of implantable monitoring devices are known in the art. (in this context, "implantable" includes devices that are inserted under the skin of a patient and deeper within the body). For example, Medtronic (Minneapolis, Minnesota) produces Reveal ^TMAn XT plug-in heart rhythm monitor (ICM) that is implanted under the chest skin and captures ECG information that can be used to diagnose arrhythmias. The ICM transmits data to nearby receivers on demand via a wireless link.

There have been many proposals in the patent literature to provide implantable medical devices with a universal wireless interface to enable communication with standard types of communication devices, such as smart phones. For example, U.S. patent 9,215,075 describes a system and method for supporting encrypted communication with a medical device, such as an implantable device, to a remote server through a relay device. Implantable medical devices are typically limited to employing low power transceivers that support short-range digital communications. A relay device such as a smartphone or Wi-Fi access point acts as a conduit for communicating with the internet or other network. The medical device negotiates a secure channel through, for example, a smartphone or router that provides application support for communications but may be isolated from the content.

Disclosure of Invention

There is provided in accordance with an embodiment of the present invention a physiological monitoring device including a housing adapted to be implanted in a patient's body and housing a communication interface, a sensor responsive to a physiological event, and a processor. The processor is configured to detect and record signals from the sensors, and to wirelessly communicate with a transmitter and receiver disposed outside the housing via the communication interface, and to receive transmissions of commands and data from the transmitter via the communication interface. The apparatus includes a memory accessible by a processor; and a battery for powering the device, wherein the device operates in one of a standby mode and an active mode, the active mode consuming more power from the battery than the standby mode, the transmissions comprising control signals transmitted by the transmitter at a first frequency in a first range of 1GHz-10 GHz; and transmission of recorded data from the sensor to the receiver at a second frequency in a second range of 400MHz-450 MHz.

According to one aspect of the apparatus, the control signal includes a wake-up command to terminate the standby mode and begin operation in the active mode.

According to another aspect of the apparatus, the control signal comprises a command to enter a standby mode of operation.

According to another aspect of the apparatus, the control signal includes a command for receiving a program modification.

According to another aspect of the apparatus, the control signal includes a command to initiate or terminate monitoring of the signal from the sensor.

According to another aspect of the apparatus, the control signal comprises a signal for transferring data from the memory to the receiver.

According to another aspect of the apparatus, the first frequency is 2.4 GHz.

According to another aspect of the apparatus, the second range is 402-MHz-405-MHz.

According to another aspect of the apparatus, the second range is 433-434-MHz.

According to another aspect of the apparatus, the physiological event is an electrical signal from a heart of the patient.

Another aspect of the device includes a battery charging circuit connected to the battery.

According to another aspect of the apparatus, the control signal includes a command to activate a battery charging circuit to charge the battery.

There is also provided, in accordance with an embodiment of the present invention, a method of physiological monitoring by providing a device adapted to be implanted in a body of a patient. The device includes a housing, a communication interface, a sensor responsive to a physiological event, and a processor configured to detect and record data from the sensor. The apparatus includes a memory accessible by the processor and a battery for powering the apparatus. The method is also implemented by: operating the device in one of a standby mode and an active mode, the active mode consuming more power from the battery than the standby mode; signals are exchanged wirelessly via a communication interface with a transmitter and a receiver arranged outside the housing. The exchange signal comprises: receiving a control signal from the transmitter at a first frequency in a first range of 1GHz-10GHz when the apparatus is in the standby mode to terminate the standby mode and begin operation in the active mode; and transmitting the recorded data from the sensor to the receiver at a second frequency in a second range of 400MHz-450MHz when the device is in the active mode; and receiving program instructions from the transmitter to operate the processor.

Drawings

For a better understanding of the present invention, reference is made to the detailed description of the invention, by way of example, which is to be read in connection with the following drawings, wherein like elements are indicated with like reference numerals, and wherein:

FIG. 1 is a schematic diagram showing the introduction of a physiological monitor according to an embodiment of the present invention;

fig. 2 is a block diagram of circuitry included in an infusion or implantable physiological monitor, according to an embodiment of the present invention;

FIG. 3 is a block diagram of circuitry 48 that may be included in an infusion or implantable physiological monitor, according to an embodiment of the present invention; and is

Fig. 4 is a flow diagram of a method of operating an injection monitor, according to an embodiment of the invention.

Detailed Description

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the various principles of the invention. It will be apparent, however, to one skilled in the art that not all of these details are required in order to practice the present invention. In such cases, well-known circuits, control logic components, and the details of computer program instructions for conventional algorithms and processes have not been shown in detail in order not to unnecessarily obscure the general concepts.

Documents incorporated by reference herein are to be considered an integral part of the present application, except that to the extent any terms are defined in such incorporated documents in a manner that conflicts with the definitions made explicitly or implicitly herein, only the definitions in this specification should be considered.

Turning now to the drawings, reference is first made to fig. 1, which is a schematic diagram illustrating the introduction of a physiological monitor according to an embodiment of the present invention. In this embodiment, the needle 10 is used to inject the sensor 12 into the subcutaneous tissue 14 of the subject. The sensor 12 is typically a sealed package (e.g., ceramic coated) that is about 2mm wide and about 2cm long. Sealing may be accomplished, for example, using the method disclosed in U.S. patent 4,785,827 entitled "sealing Assembly," which is incorporated herein by reference.

The introduction method shown in fig. 1 is exemplary and the sensor 12 can be introduced into various body tissues by many known techniques, such as catheters, endoscopes, or injection guns, without or without imaging controls. In one embodiment, the device may be placed subcutaneously at an incision of 5mm to 8 mm. Alternatively, the sensor 12 may be secured within the wall of the left ventricle of the heart using a corkscrew, helical anchor, tissue needle, threaded member, hook, barb, fastener, suture, or mesh or coating for receiving fibrous tissue growth.

The sensors 12 may be customized to detect and monitor various physiological systems, such as heart rate or neuroelectrophysiology. In an embodiment, the sensor 12 may include one or more electrodes that sense and record physiological activity, such as cardiac rhythm electrical signals. Additionally or alternatively, the sensor 12 may record data such as left ventricular blood pressure or chemical properties such as oxygen saturation, glucose levels, therapeutic drug levels, and more. In some embodiments, the sensor 12 may be provided with logic circuitry 16 (sensing), the logic circuitry 16 having sufficient analytical capability to analyze the electrical signal and characterize the arrhythmia. The circuitry 16 in the sensor 12 may detect and measure more than one parameter.

The power source 18 that powers the circuitry 16 includes a battery, which may be a rechargeable battery 20, and an RFID-based battery charging circuit 22 that is responsive to a charging signal delivered from a remote transmitter. A suitable device For the battery charging circuit 22 is disclosed in U.S. patent application publication 2010/0262029 to Kelly et al entitled "Needle Implantable Electrical agitation Monitor and methods For Use with the same," which is incorporated herein by reference.

The sensor 12 includes a wireless communication system 24 that enables it to be remotely activated and configured, and to download data to a remote receiver on command or autonomously. The communication system 24 includes an antenna 26, a receiver 28, and a short-range transmitter 30, and the communication system 24 may be implemented in a single unit as a transceiver or as a separate module, as shown in fig. 1. Suitable memory 21 is provided for storing program instructions and data obtained from circuitry 16.

Reference is now made to fig. 2, which is a block diagram of circuitry included in an infusion or implantable physiological monitor 32, in accordance with an embodiment of the present invention. The physiological monitor 32 performs the functions of the circuitry 16 and the battery charging circuit 22 in the sensor 12 (fig. 1). The physiological monitor 32 includes a near field interface 34, a control processor 36 having a system clock (not shown), a memory 38 accessible by the processor 36 for storing control instructions and data obtained from a sensor or detector 40. The microcontroller 42 is connected to other components of the physiological monitor 32 through an interface 44, which interface 44 may be a serial peripheral monitor 32 that may be activated by a remote transceiver 86, which remote transceiver 86 may be, for example, via

Connected to and controlled by a suitably configured smart phone 46.

Fig. 3 is a block diagram of circuitry 48 that may be included in an infusion or implantable physiological monitor in accordance with an embodiment of the present invention. The inventors have found that dual frequencies can be used to achieve power economy in a physiological monitor: relatively high frequencies (i.e., 1GHz-10GHz, e.g., 2.4GHz) are employed for control functions, e.g., for waking up the monitor from a standby mode, and for starting or discontinuing monitoring and battery charging. Telemetry and data transmission is performed in the industrial, scientific and medical spectrum (ISM) using relatively low frequencies: 402-. The circuit 48 includes an antenna 50 and tuners 52, 54 for low and high frequencies, respectively. The tuners 52, 54 are connected to a conventional digital transceiver 56. An implant module model ZL70323MN available from Microsemi Corp, Aliso Viejo, CA USA 92656 is suitable for transceiver 56.

A power management unit 58 including a charging circuit is connected to the transceiver 56, the power management unit 58 feeding power originating from the low frequency signal and the tuner 52. As in the embodiment of fig. 2, the operation of the circuit 48 is regulated by a microcontroller 60. Unlike the embodiment of fig. 2, the microcontroller 60 is integrated in the circuit 48 and does not require an interface for external data. Data and programs used by microcontroller 60 or recorded by the physiological monitor are stored in SRAM 62 and NVM 64.

Reference is now made to fig. 4, which is a high level flow chart of a method of operating an injection monitor, in accordance with an embodiment of the present invention. Assume at initial step 66 that the device is in a standby mode of operation. However, the method can be applied to alter any mode of operation of the device, mutatis mutandis. For example, it may be desirable to have the device cease active operation and enter an inactive or sleep mode. As another example, the method may cause the device to initiate or terminate battery charging or physiological monitoring for a set time interval, such as one hour.

At delay step 68, the method waits for a trigger signal, typically in a certain GHz range, e.g. 2.4GHz, from a transmitter, typically within 5cm, of a neighboring device. The device power consumption is 5mA average TX/RX current and 300nA average SLEEP/SNIFF current pulses in a short duration and with sufficiently low power to avoid interfering with military and government systems that widely use this frequency range. Furthermore, the signal is digitally encoded to create a unique signature of the device and thereby avoid spurious activation and interference of similar devices that may be in the vicinity, e.g., in a hospital ward. The device may be commanded using any suitable conventional communication protocol.

Next, at step 70, the mode of operation is changed in response to the ISM band signals. Step 70 includes any one or combination of

blocks

72, 74, 76, 78, 80, 82. The items in step 70 are exemplary and many other operations of the monitor may be initiated or adjusted in response to the signal. Block 72 indicates initiating the monitoring operation. Block 74 represents a command to charge the device battery. Block 72 represents a command to stop active operation and enter a low power mode. Block 78 indicates installation of the program modification. Block 80 represents a command to download data. Block 82 indicates the transmission of control instructions such as resetting the device, clearing files and other maintenance tasks, and wake-up pulses in the GHZ range as described above.

At a final step 84, the data is transferred to or from the external device. The external device may be a mobile phone optionally connected to an auxiliary transmitter or receiver. The transmission is at a different frequency, typically in the range of 400MHz-450MHz, than the signal received at delay step 68.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not in the prior art.

Claims

1. A physiological monitoring device, the device comprising:

a housing adapted to be implanted in a patient's body and to house:

a communication interface;

a sensor responsive to a physiological event;

a processor configured to detect and record signals from the sensor and wirelessly communicate with a transmitter and receiver disposed outside the housing via the communication interface and receive transmissions of commands and data from the transmitter via the communication interface;

a memory accessible by the processor; and

a battery for powering the device,

wherein the apparatus operates in one of a standby mode and an active mode, the active mode consuming more power from the battery than the standby mode, and wherein the transmitting comprises:

a control signal transmitted by the transmitter at a first frequency in a first range of 1GHz-10 GHz; and

a transmission of recorded data from the sensor to the receiver at a second frequency in a second range of 400MHz-450 MHz.

2. The apparatus of claim 1, wherein the control signal comprises a wake-up command to terminate the standby mode and begin operation in the active mode.

3. The apparatus of claim 1, wherein the control signal comprises a command to enter a standby mode of operation.

4. The apparatus of claim 1, wherein the control signal comprises a command to receive a program modification.

5. The apparatus of claim 1, wherein the control signal comprises a command to initiate or terminate monitoring of a signal from the sensor.

6. The apparatus of claim 1, wherein the control signal comprises a signal to transfer data from the memory to the receiver.

7. The apparatus of claim 1, wherein the first frequency is 2.4 GHz.

8. The apparatus of claim 1, wherein the second range is 402-MHz-405-MHz.

9. The apparatus of claim 1, wherein the second range is 433-MHz-434-MHz.

10. The device of claim 1, wherein the physiological event is an electrical signal from the patient's heart.

11. The apparatus of claim 1, further comprising a battery charging circuit connected to the battery.

12. The apparatus of claim 11, wherein the control signal comprises a command to activate the battery charging circuit to charge the battery.

13. A method of physiological monitoring, the method comprising:

providing a device adapted for implantation in a body of a patient, the device comprising:

a housing;

a communication interface;

a sensor responsive to a physiological event;

a processor configured to detect and record data from the sensor;

a memory accessible by the processor; and

a battery for powering the device;

operating the device in one of a standby mode and an active mode, the active mode consuming more power from the battery than the standby mode;

wirelessly exchanging signals with a transmitter and a receiver disposed outside the housing via the communication interface, wherein wirelessly exchanging signals comprises:

receiving a control signal from the transmitter at a first frequency in a first range of 1GHz-10GHz when the apparatus is in the standby mode to terminate the standby mode and begin operation in the active mode;

transmitting the recorded data from the sensor to the receiver at a second frequency in a second range of 400-450 MHz when the device is in the active mode; and

program instructions are received from the transmitter to operate the processor.

14. The method of claim 13, further comprising: charging the battery by activating a battery charging circuit in response to the control signal.

15. The method of claim 13, further comprising: in response to the control signal, terminating the active mode and entering the standby mode of operation.

16. The method of claim 13, further comprising: in response to the control signal, a program modification is received.

17. The method of claim 13, further comprising: in response to the control signal, monitoring of the signal from the sensor is initiated or terminated.

18. The method of claim 13, further comprising: transmitting the recorded data from the memory to the receiver in response to the control signal.

19. The method of claim 13, wherein the first frequency is 2.4 GHz.

20. The method of claim 13, wherein the second range is 402-MHz-405-MHz.

21. The method of claim 13, wherein the second range is 433-MHz-434-MHz.

22. The method of claim 13, wherein the physiological event is an electrical signal from the patient's heart.